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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE PROGRAMMING COMPUTER

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CYBERONICS, INC. PROGRAMMING SOFTWARE PROGRAMMING COMPUTER Back to Search Results
Model Number MODEL 250
Event Date 12/17/2014
Event Type  Malfunction  
Event Description

It was reported that the physician¿s programming tablet would not power on. The company representative tried using his tablet's power cable with the physician¿s tablet and a different wall outlet was used. However, the issue persisted. A replacement tablet was provided to the physician's office. The suspect tablet has not been received by the manufacturer to date.

 
Event Description

The tablet was received for analysis. An analysis was performed on the returned tablet, and the reported allegation was verified. No anomalies associated with the main battery were identified during the analysis. However, analysis confirmed a defective motherboard which contributed to the complaint. Once the board was replaced, no further anomalies associated with the tablet were identified during the analysis.

 
Manufacturer Narrative

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING COMPUTER
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4396265
Report Number1644487-2015-03559
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/17/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/08/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 250
OTHER Device ID NumberVERSION 10.0
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/16/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/29/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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